JP5114549B2 - Puncture system - Google Patents

Description

  The present invention relates to a puncture system for collecting a body fluid sample having the characteristics specified in the preamble of claim 1.

  This type of puncture system, for example, requires blood glucose levels to be checked multiple times daily, for which a body fluid sample, usually blood or interstitial fluid, is collected from the puncture wound generated by the puncture system. Used by diabetics who need it.

  This type of puncture system includes a plurality of lancets, a compartment for this type of cassette, a gradual advance mechanism that sequentially moves the lancets of the cassettes inserted into the compartment to a puncture position, and a puncture position for a puncture operation A lancet device having a puncture drive for accelerating the lancet.

  In this type of puncture system, transmission of force from the puncture drive unit to the lancet at the puncture position must be performed by an appropriate connecting means. The known coupling means are complex, require mechanical effort and require manufacturing with low tolerances, so the associated costs are substantial.

  Accordingly, it is an object of the present invention to devise a method that allows the creation of a cost-effective puncture system in the manner described above.

  This object is achieved by a puncture system having the features specified in claim 1. Further advantages of the invention are the subject matter of the dependent claims.

  In the puncture system according to the present invention, the puncture driving unit is not directly connected to the lancet. Instead, the puncture drive unit is connected by a lancet at the puncture position by the connecting means of the cassette, and the connection means connects the puncture drive unit to the lancet at the puncture position when activated. This can reduce the mechanical effort associated with connecting the lancet drive to the lancet used for puncture.

  For example, the cassette coupling means can be coupled to the puncture drive prior to inserting the cassette into the cassette compartment of the puncture device. Since accurate positioning of the connecting means with respect to the lancet or lancet carrier in the puncture position can be performed at the time of manufacture of the cassette, the connecting means of the cassette can be connected to the lancet without any burden on the user. In particular, in the case of a belt-like lancet carrier, the lancet can be accelerated for the puncture operation because it can be reliably connected to the puncture drive unit with little effort.

  Preferably, the connecting means is connected to the lancet carrier so that the lancet carrier moves with the puncture lancet during the puncturing operation. Transmission of the propulsive force generated from the lancet drive to the lancet at the puncture position from the coupling means is carried out very easily by the lancet carrier. This is because the lancet carrier can hold a predetermined position with respect to the connecting means even when the progressive mechanism used to move the new lancet of the lancet carrier to the puncture position is activated. Thus, the connecting means can be connected to the lancet carrier for further puncture with relatively little effort after each actuation of the gradual advancement mechanism, or permanently connected to the lancet carrier, i.e. the gradual advancement mechanism. It is possible to maintain the connection to the lancet carrier even during the operation of. Similarly, since the movement of the lancet carrier by the gradual advance mechanism can be performed without affecting the puncture drive unit and the cassette connection unit, a reliable connection between the cassette connection unit and the puncture drive unit is little labor. Can be realized. This ensures that the part involved in the connection of the puncture drive part is repositioned with much effort after each puncture, or accurate positioning and connection after each operation of the gradual advance mechanism by complex and costly means. This is advantageous because it does not need to be done.

  Further details and advantages of the invention will be explained on the basis of exemplary embodiments and with reference to the drawings. The features described in this process may form the subject of the claims either alone or in combination. The same and equivalent parts in the various exemplary embodiments are identified by consistent reference numerals in the drawings.

FIG. 6 is a schematic plan view of an exemplary embodiment of a cassette including a strip-shaped lancet carrier having a plurality of lancets. FIG. 4 shows an exemplary embodiment of a lancet carrier having a lancet and a test area. FIG. 2 is a side view related to FIG. 1 before puncturing. FIG. 3 is a diagram during puncturing according to FIG. 2. FIG. 4 is a schematic detail view associated with FIG. 3. FIG. 6 is a cross-sectional view illustrating details of another exemplary embodiment of a cassette. FIG. 6 is a schematic detail view of another exemplary embodiment of a connecting means of a cassette having a strip-shaped lancet carrier. FIG. 8 is a detailed view during puncturing according to FIG. 7. FIG. 8 is a perspective view related to FIG. 7. 2 illustrates an exemplary embodiment of a lancing device.

  FIG. 1 shows a cassette 1 comprising two rollers 2, 3, on which a strip-shaped lancet carrier 4 schematically shown in FIG. 2 is wound. In this regard, the first roller 2 has a part of the lancet carrier 4 with an unused lancet 5 and the second roller 3 has a used part of the lancet carrier 4. When the illustrated cassette 1 is inserted into the cassette compartment of the puncture device (not shown), the second roller 3 around which the used part of the lancet carrier 4 is wound is driven by the progressive advance mechanism of the puncture device. The lancet 5 included in the cassette 1 is sequentially moved to the puncture position. At the puncture position, the lancet 5 is positioned so as to generate a puncture wound in the body part of the user pressed against the lancet when a puncture operation is executed by the puncture drive unit of the puncture device. Body fluid samples for can be collected. By actuating a gradual advance mechanism (not shown), the driven roller 3 of the cassette 1 is enabled during rotation until the new lancet 5 of the lancet carrier 4 reaches the puncture position for puncture.

  According to FIG. 2, the lancet 5 is arranged on the strip-like lancet carrier so as to cross the longitudinal direction of the carrier. Between the two lancets 5, one test area 6 for testing a body fluid sample collected from the puncture wound is arranged. For photometric measurement of analyte concentration, test area 6 may contain test chemicals that affect concentration-dependent coloration. However, it is also possible to configure the test area 6 for electrochemical testing or spectroscopic testing of body fluid samples.

  As shown in the plan view of FIG. 1 and the side views of FIGS. 3 and 4, the cassette 1 has connecting means 7, on the other hand, the lancet 5 of the lancet carrier 4 is made movable by the operation of the progressive mechanism. Become. In operation, the connecting means 7 connects the puncture drive part of the puncture device to the lancet 5 at the puncture position. Therefore, the connecting means can transmit the propulsive force generated during puncturing by the puncture driving unit 11 to the lancet 5 at the puncture position. In the illustrated embodiment, the connecting means 7 connects the puncture drive of the puncture device to the lancet carrier 4 so that the lancet carrier 4 moves with the lancet 5 at the puncture position during puncture.

  The connecting means 7 has a container 8 for the lancet carrier 4. In the illustrated embodiment, the container has a slit shape. The container 8 forms part of a slider that can be pushed in the puncture direction with respect to the cassette housing. The connecting means 7 is permanently connected to the lancet carrier 4 via the container 8. Therefore, advantageously, since the connection means 7 is kept connected to the puncture drive section even during the operation of the gradual advance mechanism, no mechanical adjustment to the gradual advance mechanism is required.

  During puncturing, the connecting means 7 is propelled by the lancet drive in the advancing stage in the puncturing direction from the position shown in FIG. 3 to the position shown in FIG. 4 and is shown in FIG. Return to the previous position. For the connection to the puncture drive, the connection means 7 has a connection element 9 which is in the form of a pile in the illustrated exemplary embodiment, the connection element being adapted to the puncture drive by a positive fit. Engaging the connecting element.

  The propulsive force generated during puncturing by the connected puncturing drive unit causes the connecting means 7 to move in the puncturing direction together with the tape portion of the lancet carrier 4 located in the slit 8. A bending engine that is not shown and that can optionally be placed on the cassette or on the puncture drive can cause the lancet carrier tape 4 to bend as shown in FIG. As a result, the tip of the lancet 5 at the puncture position is lifted from the surface of the band-shaped lancet carrier 4 and can be punctured into the user's body in contact with the lancet 5 without being blocked by the band-shaped lancet carrier 4. The bending engine can be provided, for example, in the shape of two fork projections between which the lancet protrudes during the puncture, and the fork projections provide a band for the lancet carrier. Stop and bend on both sides adjacent to the lancet.

  After puncturing, the gradual advancement mechanism of the puncturing device is operable to position the test element 6 of the band-like lancet carrier 4 in the slit 8 of the connecting means 7. By operating the puncture drive unit again, the test region 6 can move to the puncture wound generated by the previous puncture, and the test region 6 can collect a body fluid sample.

  FIG. 5 schematically shows details of the connecting means 7 of the above-described embodiment. As is apparent from the figure, the wall of the container 8 provided in the slit shape is covered with fibers located in an oblique direction such as the stab 9. The stab 9 is arranged so that its free end is inclined with respect to the return direction. As a result, the lancet carrier 4 is held by the stab 9 during the return operation of the connecting means 7 and can be retracted together with the connecting means 7 by the puncture driving part connected thereto. Thus, in the illustrated exemplary embodiment, the connecting means 7 contacts the lancet carrier 4 via a structured connecting surface, which is connected according to the relative direction of movement. In contrast to the surface, it provides resistance to the relative movement of the lancet carrier 4.

  This kind of connecting surface does not obstruct the movement of the lancet carrier 4 by the progressive advance mechanism at all or almost because the structural surface provides an increase in friction only in the direction of the return movement. During the return operation, the structural surface of the connecting surface of the container 8, ie the opposing side walls of the slit 8 in the illustrated exemplary embodiment, provides improved adhesion of the lancet carrier 4 within the container 8. Therefore, the lancet carrier 4 can be quickly retracted together with the connecting means 7, and the lancet 5 of the lancet carrier 4 can be retracted from the puncture wound just generated.

  A structural surface having such advantageous characteristics can be obtained not only by the fibers 9 shown in FIG. 4 but also by other protrusions, ridges or recesses of the connecting surface of the container 8 in contact with the surface of the lancet carrier 4. Is possible.

  The structural surface according to FIG. 5 can be achieved, for example, by coating with parallel short fibers. The fiber 9 is fixed to the fixed layer. The fibers are oriented at an angle between 30 ° and 90 °, preferably between 45 ° and 75 ° with respect to the connecting surface of the container 8. In this connection, the fibers are inclined in the direction of the bottom of the slit, i.e. the direction of the return movement and the direction of the force acting on the lancet carrier 4 by the connecting surface 8, as shown in FIG.

  The movement of the two connecting surface lancet carriers 4 of this type of structure is advantageously performed with little friction. Insertion of the band-like lancet carrier 4 into the container 8 also causes only slight friction. However, if the movement of the lancet carrier 4 in the direction opposite to the inclination direction of the fibers 9 is attempted, the lancet carrier 4 is restrained because the lancet carrier 4 is also caught. For example, the flock fiber film can be used as a structural connection surface having the inclined fibers 9, and can be applied to the connection means, in particular, by adhering to the connection means.

  A suitable flock fiber film can be produced, for example, as follows. For example, a Hostafan RN50 polyester film manufactured by Mitsubishi Polyester Film, Wiesbaden, is coated with a conductive adhesive such as, for example, Mecoflock D453 / 5-09 from Kissel + Wolf, Wiesloch, Germany. The adhesive layer is then flocked with a polyamide flock of 0.5 dtex and a length of 0.5 mm using an Ero-Mini flocking device manufactured by Maag Flockmaschinen, Gomerlingen, Germany. This type of flock is available from Swissflock, Stuttgart, Germany. Immediately after flocking, the film is pulled through a calendar set at a roll spacing of, for example, 360 μm. Thereby, a fiber is orientated diagonally. After drying, the folock layer is evacuated and cleaned by removing frayed fibers. Thereafter, the fibers have an angle of about 45 ° to the polyester film in the winding direction. The fibers are, on average, oriented perpendicular to the winding direction.

  Another option for producing a suitable flock fiber film is to fold the plastic film alternately in parallel up and down at intervals of 10 mm, for example, so that the bends are 100 ° to 140 °, for example 120 °, respectively. Have an angle. The floc is then applied to the film as in the previous example, but after that the film does not move between the rolls. This is because the fibers are rapidly sent to the adhesive by the inclination of the film portion, so that the fibers are positioned at an angle of about 60 to 70 ° with respect to the film.

  The groove of the connecting means 7 shown in FIG. 5 can have a width of, for example, 0.8 mm. The flock fiber film can be adhered to the slit wall using, for example, an epoxy adhesive, and according to FIG. 5, this directs the fibers 9 towards the slit bottom.

  FIG. 6 shows another exemplary embodiment of the cassette 1 with connecting means 7. Similar to the cassette 1 shown in FIG. 1, the cassette 1 shown in FIG. 6 includes a strip-shaped lancet carrier 4 having a plurality of lancets 5 arranged according to FIG. This cassette 1 basically differs from the previous embodiment only in the design of the connecting means 7, and during operation, the connecting means applies the propulsive force generated from the puncture drive unit during puncture to the puncture position. In order to transmit to a certain lancet 5, the puncture driving unit of the puncture device is connected to the lancet carrier 4.

  The connecting means 7 includes a slider 10 positioned so as to be movable with respect to the cassette housing 11. The slider 10 has a recess 9 that engages with the puncture driving unit 11 by a pile as a connecting element for connecting to the puncture driving unit of the puncture device, whereby the slider 10 is generated by the puncture driving unit 11. It becomes possible to move in the puncture direction by the propulsion force.

  For connection to the lancet carrier 4, the illustrated connection means 7 has a container 8 through which the lancet carrier 4 is guided. The container 8 is movable on the slider 10 and the pressing element 12 which is movable with respect to the connecting surface 16 and which releases the lancet carrier 4 in the container during puncture and releases it again after completion of the return operation after puncture. It is formed by a connecting surface 16 that is fixedly arranged.

  The pressing element 12 can be rotated around the rotation point 13 by being disposed on the slider 10. The spring element 14 presses the rear end portion of the pressing element 12 against the connecting member 15 integrated in the cassette housing 11 in the illustrated embodiment. By moving the slider 10 in the puncture direction, the rear end portion of the pressing element 12 travels along the connecting member 15 and can be rotated by this arrangement, and the front end portion is connected to the connecting surface 16 of the slider 10. A closing action of pressing against the lancet carrier 4 can be carried out, so that the lancet carrier 4 is clamped between the connecting surface 16 and the front end of the pressing element 12. Thereby, the connecting means 7 of the illustrated exemplary embodiment grips the lancet carrier 4 in a fastening manner during puncturing and releases it again after completion of the return operation after puncturing. The clamping of the lancet carrier 4 in the container 8 allows the lancet carrier 4 to return quickly and reliably during the return operation, whereby the lancet carried on the carrier is quickly withdrawn from the generated puncture wound. It is. This is important in connection with the least pain possible with a puncture.

  In the illustrated embodiment, the clamping force for clamping the lancet carrier 4 is provided by a spring element 14 that presses the rear end of the pressing element 12 against the connecting member 15, the connecting member during the puncturing operation. The closing action of the pressing element 12 is defined as follows.

  FIGS. 7 to 9 show another embodiment of the connecting means 7, which can be used instead of the previous connecting means 7 described above, for example in the case of the cassette 1 of FIG. is there. Similar to the connecting means 7 shown in FIG. 6, the connecting means 7 shown in FIGS. 7 to 9 holds the lancet carrier 4 in a clamping manner during puncturing, and again after completion of the return operation after puncturing. Release this. FIG. 7 therefore shows the connecting means 7 with the released lancet carrier 4 before puncturing. In FIG. 8, the lancet carrier 4 is fastened by the connecting means 7, and a clear state during puncture is shown. FIG. 9 shows an oblique view of a part of the connecting means 7 shown in FIGS.

  Similar to the embodiment shown in FIG. 6, the connecting means 7 of the embodiment shown in FIGS. 7-9 comprises a slider 10 which can be propelled in the puncture direction, through which the lancet carrier 4 is It has a container 8 to be supplied. In FIG. 8, the puncture direction is indicated by a dotted line. The container 8 of the lancet carrier 4 can be provided in a slot shape, for example.

  The container 8 interacts with a pressing element 12 that presses the lancet carrier 4 against the connecting surface of the container 8 during puncturing and fastens it. The clamping force for clamping the lancet carrier 4 is provided by a spring element 14 provided by the same components as the pressing element 12 in the illustrated embodiment. The spring element 14 interacts with an opener 17 located in a fixed position relative to the cassette housing (not shown) in the illustrated embodiment, and can be provided, for example, in a protruding manner on the cassette housing. .

  When the slider 10 is in the starting position shown in FIG. 7 before puncturing, the opener 17 presses the spring element 14, thereby opening the container 8. Thereafter, the lancet carrier 4 is movable in the container 8 perpendicularly to the puncture direction by actuating a progressive advance mechanism (not shown). By moving the slider 10 in the puncture direction, the spring element 14 is separated from the opener 17, thereby securing the lancet carrier 4 in the container 8. Thereby, the spring force acting by the spring element 14 presses the lancet carrier 4 against the connecting surface of the container 8.

  The spring element 14 can be manufactured inexpensively from a plastic material. However, the spring element 14 can also be made of metal.

  FIG. 10 shows an embodiment of a puncture device for collecting a body fluid sample. The puncture device 20 has an opening 21 that is pressed against the body to generate a puncture wound. The puncture device 20 further includes a key-like actuating element 22 and a liquid crystal display type display device 23 for displaying the test result. The puncture device 20 has a compartment (not shown) for receiving a cassette 1 containing a lancet carrier 4 with a plurality of lancets 5. An exemplary embodiment of this type of cassette 1 has been described with reference to FIGS. The compartment of the illustrated puncture device 20 has an opening that can be closed and is arranged on the rear side of the illustrated puncture device 20.

  A measurement and analysis facility (not shown) is integrated into the illustrated lancing device 20 and can be used to measure the analyte concentration of a body fluid sample. For this purpose, it is taken up by the test area 6 of the lancet carrier band 4 contained in the cassette 1 (see FIG. 2) inserted after the generation of the puncture wound. The sample is collected by positioning the test region 6 of the lancet carrier band 4 below the device opening 21 by activating the progressive mechanism. By operating the puncture drive unit again, the lancet carrier 4 having the test region 6 can be moved in the puncture direction, whereby the puncture wound of the body part pressed against the device opening 21 to take in the body fluid sample. A test area 6 is arranged.

  The puncture device shown in FIG. 10 and the cassette 1 described with reference to FIGS. 1 to 9 collectively form a puncture system.

DESCRIPTION OF SYMBOLS 1 Cassette 2 Roller 3 Roller 4 Lancet carrier 5 Lancet 6 Test area 7 Connection means 8 Container for lancet carrier 9 Linking element / stab 10 Slider 11 Puncturing drive part 12 Pressing element 13 Turning point 14 Spring element 15 Connection member 16 Connecting surface 17 Opener 20 Puncture device 21 Device opening 22 Actuating element 23 Display device

Claims (13)

A puncture system for collecting a body fluid sample,
At least one cassette (1) comprising a lancet carrier (4) with a plurality of lancets (5) and a compartment for such a cassette (1), contained in a cassette (1) inserted into the compartment A gradual advance mechanism for continuously moving the lancet (5) to the puncture position, and a puncture device having a puncture drive unit (11) for accelerating the lancet (5) at the puncture position for the puncture operation A puncture system,
The cassette (1) has connecting means (7) having a container (8) for the lancet carrier (4), the container (8) being movable relative to the cassette housing (11); The lancet (5) of the lancet carrier (4) becomes movable with respect to the container (8) by gradually operating the advance mechanism, and the container (8) punctures the puncture drive unit (11) when activated. Connected to the lancet (5) at the position, and transmitting the propulsive force generated by the puncture drive unit (11) to the lancet (5) at the puncture position during puncturing ,
Puncture system wherein the lancet (5), is arranged so as to cross the longitudinal direction of the lancet carrier (4), characterized in Rukoto. The puncture system according to claim 1, characterized in that the lancet carrier (4) is strip-shaped. The lancet carrier (4) has a test area (6) for testing a body fluid sample taken from a puncture wound, the test area being arranged between the lancets (5). The puncture system as described. The linking device (7) is connected to a lancet carrier (4) and moves together with the lancet (5) at the puncture position during puncturing. Puncture system. The puncture system according to claim 4, characterized in that the connection means (7) is held connected to the lancet carrier (4) during operation of the progressive mechanism. The puncture system according to any one of claims 1 to 5, wherein the connection means (7) is held connected to the puncture drive section (11) during the operation of the progressive mechanism. The connection means (7) grips the lancet carrier (4) in a fastening manner during puncturing, and releases it again after completion of the return operation after puncturing. The puncture system according to item 1. 8. Puncture system according to claim 7, characterized in that the coupling means (7) comprise a spring element (14) for producing a clamping force for clamping the lancet carrier (4). Puncture system according to any one of the preceding claims, characterized in that the coupling means (7) contact the lancet carrier (4) via a structured coupling surface (16). Said connecting means (7) contacts the lancet carrier (4) via a contact surface (16) with fibers (9) inclined in the return movement direction performed by the lancet (5) after the advancement stage during puncturing. The puncture system according to any one of claims 1 to 9, wherein: The structured connecting surface (16) provides resistance to the relative movement of the lancet carrier (4) and the connecting surface (16) with respect to each other, the resistance depending on the direction of the relative movement The puncture system according to claim 9 or 10. A cassette for a puncture device for collecting a bodily fluid sample, the cassette (1) comprising a lancet carrier (4) having a plurality of lancets (5) and also for cassettes (1) for puncturing operations The cassette (1) connects the lancet carrier (4) to the puncture drive unit (11) of the puncture device, which can be inserted into the puncture device including the puncture drive unit (11) for accelerating the included lancet (5). Connecting means (7) for connecting the container (8) to the cassette housing (11), the connecting means (7) having a container (8) for the lancet carrier (4). In contrast, the container (8) transmits a propulsive force to the lancet (5) in which the container (8) is at the puncture position, and the propulsive force is generated during puncture by the puncture drive unit (11) connected to the container (8) It is,
Cassette wherein the lancet (5), is arranged so as to cross the longitudinal direction of the lancet carrier (4), characterized in Rukoto. A puncture device for collecting a bodily fluid sample having a compartment for a cassette (1), the compartment comprising a lancet carrier (4) having a plurality of lancets (5) and a cassette ( A gradual advance mechanism for sequentially positioning the lancet (5) included in 1) at the puncture position, and a puncture drive unit (11) for accelerating the lancet (5) at the puncture position, The lancet drive (11) is configured to be connected to the lancet carrier (4) via the connecting means (7) of the inserted cassette (1), and the lancet (5) is in the puncture position for puncturing. to accelerate,
Lancing device wherein the lancet (5), is arranged so as to cross the longitudinal direction of the lancet carrier (4), characterized in Rukoto.

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